National Health Act 1953 - Amendment declaration under subsections 85(2) and 85(2AA) - Amendment determination under subsection 85(2A) - drugs and medicinal preparations (No. PB 78 of 2007)

Overview

The National Health Act 1953, enacted by the Parliament of Australia, establishes the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have reliable, timely, and affordable access to a broad range of medicines. The Act enables the Commonwealth to provide pharmaceutical benefits by declaring certain drugs and medicinal preparations through legislative instruments. The 2007 amendment to the Act, specifically F2007L03942, refines the declarations and determinations concerning listed drugs, including the form, administration, and brand specifications, based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent expert body, consults with stakeholders to assess the clinical effectiveness, safety, and cost-effectiveness of drugs before recommending their listing on the PBS. This amendment, effective from 1 November 2007, includes updates such as the addition of new drugs like Bortezomib and Tamarindus indica seed polysaccharide, modifications to existing drug listings, and the removal of certain drugs from the PBS. The legislative instrument underscores the importance of expert advice and stakeholder consultation in maintaining the integrity and efficacy of the PBS.

Scope and Application

The National Health Act 1953 Amendment Instrument PB 78 of 2007 amends the Pharmaceutical Benefits Scheme (PBS) as outlined in Part VII of the Act, providing a legislative basis for the Commonwealth to offer reliable, timely, and affordable access to a broad range of medicines for all Australians. The instrument applies to drugs and medicinal preparations declared as listed drugs by the Minister, as per subsection 85(2), and includes certain extemporaneously-prepared medicinal preparations. The Minister can further determine the forms, manner of administration, and brands of these listed drugs through legislative instruments. This instrument, which commenced on 1 November 2007, amends previous declarations and determinations made by legislative instrument number PB 48 of 2007, effective from 1 August 2007, with specific amendments detailed in Schedule 1. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending which drugs should be listed on the PBS, considering factors such as clinical effectiveness, safety, and cost-effectiveness. The PBAC's advice is mandatory for the Minister when considering revocations or variations of drug listings.

Key Provisions

The National Health Act 1953, as amended by the legislation F2007L03942, primarily operates through its Part VII to administer the Pharmaceutical Benefits Scheme (PBS). Section 85(1) stipulates that the Commonwealth is to provide benefits in accordance with Part VII, specifically concerning pharmaceutical benefits. The Minister is empowered under section 85(2) to declare drugs and medicinal preparations that fall under the PBS through legislative instruments, listing them as defined in section 84(1). These declarations include certain extemporaneously-prepared medicinal preparations as per paragraph 85(2)(b). Furthermore, section 85(2AA) allows the Minister to revoke or vary these declarations through legislative instruments, subject to the advice of the Pharmaceutical Benefits Advisory Committee (PBAC) when such actions would result in a drug or medicinal preparation ceasing to be listed. The PBAC advice must be tabled in Parliament as per subsection 85(2AC). Additionally, section 85(2AB) mandates that the Minister obtain PBAC advice in writing before revoking or varying a declaration that would result in the cessation of a drug or medicinal preparation from being listed. Section 101(4) stipulates that a drug or medicinal preparation cannot be declared under section 85(2)(a) unless the PBAC has recommended it to the Minister. The Act imposes several obligations on the parties it governs. The Minister must consult with the PBAC, an independent expert body established by section 100A, when making decisions about which drugs and medicinal preparations should be included in the PBS. The PBAC is tasked with making recommendations based on factors such as the medical conditions for which a medicine has been approved, its clinical effectiveness, safety, and cost-effectiveness compared to other treatments. The Minister is also required to consider the PBAC's advice when revoking or varying declarations under section 85(2). Additionally, the Minister must ensure that any new declarations or variations comply with the recommendations of the PBAC, as stipulated by section 101(4). Failure to comply with the provisions of the National Health Act 1953 and its amendments can result in various penalties and consequences. While the explanatory statement does not explicitly list specific penalties, breaches of legislative instruments generally carry administrative, civil, or criminal penalties depending on the severity of the breach and the specific provisions involved. For example, non-compliance with declarations or determinations under the Act may lead to legal actions, fines, or other administrative penalties. In more severe cases, breaches could result in criminal charges, particularly if they involve fraudulent activities or deliberate non-compliance. The exact penalties would depend on the specific circumstances and the relevant laws governing such actions.